Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months-5 Years - United States, June 2022.

ABSTRACT

On June 17, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) amendments for the mRNA-1273 (Moderna) COVID-19 vaccine for use in children aged 6 months-5 years, administered as 2 doses (25 µg [0.25 mL] each), 4 weeks apart, and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine for use in children aged 6 months-4 years, administered as 3 doses (3 µg [0.2 mL] each), at intervals of 3 weeks between doses 1 and 2 and ≥8 weeks between doses 2 and 3. On June 18, 2022, the Advisory Committee on Immunization Practices (ACIP) issued separate interim recommendations for use of the Moderna COVID-19 vaccine in children aged 6 months-5 years and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months-4 years for the prevention of COVID-19.* Both the Moderna and Pfizer-BioNTech COVID-19 vaccines met the criteria for immunobridging, which is the comparison of neutralizing antibody levels postvaccination in young children with those in young adults in whom efficacy had been demonstrated. Descriptive efficacy analyses were also conducted for both Moderna and Pfizer-BioNTech COVID-19 vaccines during the period when the Omicron variant of SARS-CoV-2 (the virus that causes COVID-19) predominated. No specific safety concerns were identified among recipients of either vaccine. ACIP recommendations for the use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months-5 years and 6 months-4 years, respectively, are interim and will be updated as additional information becomes available. Vaccination is important for protecting children aged 6 months-5 years against COVID-19.